Healthcare & Life Sciences

As of 2026-05-29

Life sciences (Pharma block, 14%, §17.11) is the vertical where the system's validated state is a design constraint — in GxP, changing an analytics model is itself regulated. Validated systems (GAMP 5, FDA 21 CFR Part 11, EMA) require formal change control + audit trails; design analytics to be validatable, don't retrofit. ALCOA+ is the data-integrity bar, making lineage (M077) and retention (M071) compliance primitives. Keep the regulated estate (manufacturing/quality/serialization/clinical) cleanly separated from the commercial estate. Batch genealogy + serialization are the signature high-integrity data shapes. The validation barrier excludes generalists → scarce, rate-setting work.